- Serve as representative for QC system owners, supporting operational and compliance activities.
- Review and approve validation lifecycle documentation.
- Oversee commissioning, qualification, decommissioning, and related documentation, including exception handling and closure.
- Provide guidance on equipment/system qualification and decommissioning activities.
- Support change control assessments and reviews.
- Conduct data integrity assessments and ensure compliance with internal and regulatory standards.
- Offer input and direction on qualification and decommissioning activities where applicable.
- Prior experience in biotech or pharmaceutical operations is preferred.
- Strong knowledge of validation approaches, strategies, and philosophies.
- Familiarity with laboratory instruments, computerized system validation, and qualification of controlled temperature chambers.
- Experience with electronic validation tools (e.g., KNEAT) is advantageous.
- Solid understanding of change control methodology, GMP, GDP, and data integrity principles.
- Strong interpersonal and communication skills, with the ability to collaborate across teams and vendors.
- Team‑oriented mindset with focus on safety, quality, and timelines.
- Ability to work independently with minimal supervision.
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Serve as representative for QC system owners supporting operational activities Review and approve validation lifecycle documentation Provide guidance on equipment/system qualification activities Support change control assessments Conduct data integrity assessments ensuring compli ...
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QC Systems Specialist - Singapore - Coalesce Management Consulting
Description
Responsibilities:
Requirements:
What we offer
At Coalesce Management Consulting Pte. Limited, we are committed to providing our employees with a supportive and rewarding work environment. We offer competitive remuneration, opportunities for career growth and development, and a range of benefits to support your wellbeing. Join our dynamic team and contribute to the success of our clients' projects.
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System Specialist
Only for registered members Singapore, Singapore, Singapore
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Systems Specialist
Full time DHL Express (Singapore) Pte. Ltd- Singapore
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Systems Specialist
Full time Only for registered members Singapore
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Systems Specialist
Only for registered members Singapore
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Systems Support Specialist
ESET- Singapore
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Systems Support Specialist
Only for registered members Singapore
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DCIM System Specialist
Full time Only for registered members Singapore
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System audit specialist
Only for registered members Singapore
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QC Systems Specialist
Only for registered members Singapore
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HR Systems Specialist
Only for registered members Singapore
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Senior System Specialist
Only for registered members Singapore
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DCIM System Specialist
Only for registered members Singapore
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Finance Systems, Specialist
Only for registered members Singapore
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Finance Systems, Specialist
AIA Singapore- Singapore
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System Management Specialist
Only for registered members Singapore, Singapore
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Finance Systems, Specialist
Full time Only for registered members Singapore
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QA System Specialist
Only for registered members Bugis
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Air Defence Systems Specialist
Republic of Singapore Air Force- Singapore
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Specialist IS Business System Analyst
Amgen- Singapore
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Specialist IS Business System Analyst
Amgen- Singapore